Reversal of Spinal Anesthesia Residual Motor Block Via Intrathecal Catheter

NCT07404982 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 2025P000372
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the feasibility of administering a predetermined amount of normal saline into the intrathecal or subarachnoid space via a small spinal catheter to reduce or eliminate the effects of previously injected spinal anesthetic following lower extremity orthopedic surgery.

Conditions

Joint Replacement Surgery

Keywords

Joint Replacement; Knee Replacement

Outcome Measures

Primary Outcomes (1)

• Time to residual motor blockade reversal

  Time to residual motor blockade reversal as measured by Bromage score following saline administration and catheter removal, up to a maximum of 60 minutes.

  Initiation of spinal anesthetic to reversal, up to sixty minutes after removal of catheter.

Study Arms (2)

Control

NO INTERVENTION

Patients randomized to the control group will receive a combined spinal intrathecal catheter and the same dosing of spinal medications. All aspects of care and monitoring will be the same as non-study patients. The control group will not receive a dose of intrathecal saline post-op

Saline administered via the intrathecal catheter

EXPERIMENTAL

Patients randomized to the Intervention group will be administered 10ml of sterile normal saline via the intrathecal catheter post-op prior to catheter removal.

Drug: Normal Saline 10 mL Injection

Interventions

Normal Saline 10 mL Injection DRUG

Patients randomized to this arm will have saline administration via intrathecal catheter post-op prior to removal

Saline administered via the intrathecal catheter

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients having elective lower extremity joint replacement surgery
• Patients \>18 years

You may not qualify if:

• Contraindications to spinal anesthesia (refusal, lumbar spinal hardware, spinal abnormalities)
• Patient on anticoagulation not withheld
• Patient receiving re-operation on the same joint
• Prior intra-cranial bleeding
• Patient's ASA status \>3
• Non-English speaking

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Interventions

Saline Solution; Injections

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Anna Fratello

CONTACT

617-632-8058; afratell@bidmc.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 12, 2026
• Study Start: March 19, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

US (1)